ClinicalTrials.gov
ClinicalTrials.gov Menu

New York City Mobile Interventional Stroke Team (NYC MIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03048292
Recruitment Status : Enrolling by invitation
First Posted : February 9, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

Endovascular treatment has recently become the recommended therapy for acute stroke after the publication of five randomized trials (MR CLEAN1, ESCAPE2, EXTEND IA3, SWIFT PRIME4, REVASCAT5) in 2015 that demonstrate its efficacy. Hospitals need to adapt to these updated stroke care guidelines, and many hospitals are not appropriately equipped for neurointerventional procedures. Decreased time to treatment is associated with favorable clinical outcomes, and best practices to optimize workflow between comprehensive stroke centers and secondary hospitals have become an important area of study. This prospective study is being conducted on acute stroke cases within the Mount Sinai Health System from 1 June 2016 up until 31 December 2018. The researchers would like to evaluate how variable methods of interventional service delivery for acute stroke affect clinical measures and outcomes.

More specifically, the researchers are conducting this study in order to determine whether outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting to and receiving treatment at a comprehensive stroke center, will be superior to that delivered by a mobilized intervention team at a central satellite hospital. In particular, the hypothesis is that factors affecting outcome include presentation to secondary hospital, delays with transfer including traffic conditions and time of day, and the acquisition of complex imaging within secondary hospitals.


Condition or disease Intervention/treatment
Acute Stroke Other: Acute Endovascular Stroke Treatment

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reducing Disparities in Mechanical Embolectomy Access for Patients of New York City Via a Mobile Interventional Stroke Team: Systems of Care and Time-To-Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
Mobilized Neurointervention Team
Patients undergoing endovascular stroke interventions.
Other: Acute Endovascular Stroke Treatment
Other Names:
  • Solitaire
  • Trevo
  • Embotrap
  • Medtronic
  • Stryker
  • Neuravi
  • Penumbra
  • Microvention

Mobilized Patient Other: Acute Endovascular Stroke Treatment
Other Names:
  • Solitaire
  • Trevo
  • Embotrap
  • Medtronic
  • Stryker
  • Neuravi
  • Penumbra
  • Microvention

Core Comprehensive Stroke Center Treatment Other: Acute Endovascular Stroke Treatment
Other Names:
  • Solitaire
  • Trevo
  • Embotrap
  • Medtronic
  • Stryker
  • Neuravi
  • Penumbra
  • Microvention




Primary Outcome Measures :
  1. Treatment times [ Time Frame: 90 days ]
    Time between first hospital arrival and final recanalization


Secondary Outcome Measures :
  1. Time to groin puncture procedure [ Time Frame: 3 months ]
    Time of first hospital arrival to groin puncture

  2. Time of EMS contact to groin puncture [ Time Frame: 90 days ]
  3. NIHSS [ Time Frame: 90 days ]

    National Institutes of Health Stroke Scale (NIHSS) a 11-item impairment scale to evaluate neurologic outcome and degree of recovery.

    Each item is scored between 0 and up to 4, (0 normal function with higher score indicating higher level of impairment. with minimum score 0 and maximum possible score 42.


  4. modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    the mRS measures degree of disability/dependence after a stroke. the mRS is a scale that runs from 0 (no symptoms) to 6 (death).


Biospecimen Retention:   Samples With DNA
Blood Clot; Saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who consent to the study and present with acute stroke treated with thrombectomy in the Mount Sinai Health System.
Criteria

Inclusion criteria:

- all patients who consent to the study and present with acute stroke treated with thrombectomy in the Mount Sinai Health System (Mount Sinai, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai St. Luke's) from 1 June 2016 - 31 December 2018.

Exclusion criteria:

  • If the patient is pregnant
  • Under age 18
  • A prisoner. If timing of treatment cannot be captured, patients with these data points will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048292


Locations
United States, New York
Mount Sinai Beth Israel
New York, New York, United States, 10003
Mount Sinai West
New York, New York, United States, 10019
Mount Sinai St Luke's
New York, New York, United States, 10025
Mount Sinai Health System
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Johanna Fifi, MD Icahn School of Medicine at Mount Sinai

Publications:
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum in: N Engl J Med. 2015 Jan 22;372(4):394.

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03048292     History of Changes
Other Study ID Numbers: GCO 16-1290
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Embolectomy
Embolus
Thrombectomy
Thrombolysis
Thrombus
Mobile
Interventional
Neurointervention
Stroke
Ischemic
Acute
Endovascular
Cerebrovascular
Clot
Stent Retriever
Tissue Plasminogen Activator
Drip and Ship
Mothership
Trip and Treat

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases